Evaluation of the Benefits of Shampoo During 4 Weeks of Treatment and After 24 Weeks

NCT ID: NCT07292467

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-19
• Study Completion Date: 2026-01-30

Brief Summary

The goal of this study to evaluate the efficacy of shampoo after 4 weeks (treatment phase) and after 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase) on subjects with moderate to severe dandruff and severe itching state.

Participants will:

Apply investigationnal products 3 time a week during 4 weeks and investigational product once a week and neutral product twice a week during 24 weeks Visit the center 10 times during the study for evaluations Keep a diary of their discomfort and the number of times they use the investigational products

Detailed Description

=> after 4 weeks (treatment phase) and 5 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks with 1 application per week (maintenance phase)

Primary objective :

• To evaluate the reduction of total dandruff ( adherent and non-adherent)

Secondary objectives:

• To evaluate the Quality of Life (QoL) evolution
• To evaluate the reduction of discomfort (itching, stinging, burning sensation)
• To evaluate the reduction of scales
• To assess the cosmetic properties of investigational product
• To assess the tolerance of investigational product

Conditions

Dandruff

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Shampoo

Selenium disulfide

Intervention Type: OTHER

1% SeS2

Interventions

Selenium disulfide

1% SeS2

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• At baseline: A moderate to severe level of squames: Total squames score (adherent + non-adherent) ≥ 4 (ranging from 0 to 10) including an adherent squames score ≥ 2.5 (ranging from 0 to 5) and no limit for non-adherent squames score at inclusion (The groups must be balanced to ensure an equitable distribution)
• All types of scalp.
• Any phototype
• Questionnaire inclusion: Food habits and sleep (at least 30 vols per item, a subject can be included in both groups)
• Severe itching score ≥ 7
• Subject with hair length > 2 cm.
• Subject having received the information about the study modalities and having given his/her written consent and having signed the "informed consent form" specific for this study, in accordance with the corresponding procedure.
• Subject usually using a shampoo 3 times a week and accepting to follow a rate of 3 times a week during the whole study period.
• Subject agreeing not to use any other hair product other than the ones provided for the study (till the end of study); in particular:

• no styling product (tonic, spray, lotion, foam) three days before the study visit.
• no treating haircare product (conditioner, hair mask, non-rinsed hair care product, oil….).
• no anti-scales products (whatever the type: shampoo, treatment...).
• no hair coloring or hair bleaching within one week prior to any study visit.
• Subject agreeing not to have a short haircut during the entire study period.
• Subjects in good general and mental health in the opinion of the investigator
• Subjects demonstrating understanding of the study procedures, restrictions, and willingness to participate as evidenced by voluntary written informed consent and having received a signed and dated copy of the informed consent form
• Subjects who have agreed to comply with the procedures and requirements of the study and to attend the scheduled assessment visits

Exclusion Criteria

• Subject with scalp psoriasis
• Subject with more than 60% of white hair influencing the scoring of scales.
• Subject who has skin marks on the scalp that could interfere with the assessment (pigmentation trouble, scar elements…).
• Subject with alopecia in vertex (stage > IIIa Hamilton and > I Ludwig)
• Subject who has used topic treatment for the scalp (anti-hair loss, soothing…) during the last three weeks before the start of the study.
• Subject who has used products for the scalp (dyeing, bleaching, permanent waving and straightening …) within the three weeks prior to the study.
• Subject with history of allergy and/or reactions to latex.
• Subject who has taken:

• Corticoids (local or per os) within 2 weeks before the study entry
• Anti-histaminic, anti-fungal, non-steroidal anti-inflammatory, immunosuppressive orlithium-based drugs less than 1 month before the study entry,
• retinoid acid (local or per os) since less than 6 months before study entry.
• Subject practicing regularly water sport and/or having regular sauna sessions.
• Subject exposed to the sun or UV rays in an excessive way during the last month (according to the investigator).
• Pregnancy, breastfeeding, childbearing potential without adequate contraception, or irregular menstrual cycles.
• History of drug or alcohol abuse
• History or suspicion of unreliability, poor cooperation or noncompliance with medical treatment
• Topical treatment of the scalp with other antifungal medication or with corticosteroids in the last 3 weeks before the start of the study.
• Systemic use of erythromycin, tetracycline or any of its derivatives, trimethoprim/sulfamethoxazole, or metronidazole within 28 days before the start of the study
• Subject with personal history of allergy and/or adverse reactions to cosmetic products containing surfactant agents (soaps, shower gel, conditioner …)
• Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
• Clinical signs and/or history of immunosuppression
• Severe disease (e.g. cancer, cardiac infarct, unstable angina pectoris pectoris)
• Treatment with any other investigational drug in the 4 weeks prior to study entry
• Employee of the sponsor or the study site

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vichy Laboratoires

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gitanjali PETKAR, Dr

Role: PRINCIPAL_INVESTIGATOR

CIDP

Locations

CIDP

Phoenix, , Mauritius

Countries

Mauritius

Other Identifiers

VCY 25-001

Identifier Type: -

Identifier Source: org_study_id